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National Health (Pharmaceutical Benefits) Regulations 2017
5Interpretation
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#### 5 Interpretation
> Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) Chief Executive Medicare;
(b) public hospital;
(c) public hospital authority.
(1) In this instrument:
> Act means the National Health Act 1953.
> additional patient charge means the further additional patient charge referred to in clause 6.2.1(c) of the Eighth Community Pharmacy Agreement, as in force on 1 July 2024.
> Note: The charge is based on a formula that takes into account whichever of the general patient charge, general patient reduced charge or concessional beneficiary charge is applicable to a supply under Part VII of the Act.
> applicable amount has the same meaning as in Part VII of the Act.
> approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.
> approved hospital authority has the same meaning as in Part VII of the Act.
> approved information technology requirements means information technology requirements of a kind approved by the Secretary under section 12 for the purposes of the provision in which the expression is used.
> approved medical practitioner has the same meaning as in Part VII of the Act.
> approved pharmacist has the same meaning as in Part VII of the Act.
> approved residential care home has the meaning given by the Aged Care Act 2024.
> approved supplier has the same meaning as in Part VII of the Act.
> authorised midwife has the same meaning as in Part VII of the Act.
> authorised nurse practitioner has the same meaning as in Part VII of the Act.
> authorised optometrist has the same meaning as in Part VII of the Act.
> authority approval number, for an authority prescription, means the number allotted to the prescription when the prescription is authorised by the Minister or the Chief Executive Medicare.
> authority prescription means a prescription that prescribes a pharmaceutical benefit and that:
(a) has been written in accordance with an authorisation under section 30; or
(b) has been authorised in accordance with authority required procedures that:
(i) are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or
(ii) are part of the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit; or
(c) if neither paragraph (a) or (b) applies—has been authorised as part of the circumstances determined for the pharmaceutical benefit under subsection 85B(4) of the Act.
> brand, of a pharmaceutical item, has the same meaning as in Part VII of the Act.
> Commonwealth price has the same meaning as in Part VII of the Act.
> concessional beneficiary has the same meaning as in Part VII of the Act.
> concession card has the same meaning as in Part VII of the Act.
> CTS claim has the same meaning as in Part VII of the Act.
> data collection period, for a brand of a pharmaceutical item, has the meaning given by section 67.
> deferred supply authorisation means a deferred supply authorisation prepared under paragraph 53(3)(a).
> delisted brand, of a pharmaceutical item: a listed brand of a pharmaceutical item becomes a delisted brand when a determination made under subsection 85(6) of the Act is no longer in force for that brand.
> dependant, in relation to a concessional beneficiary, has the same meaning as in Part VII of the Act.
> drug in a pharmaceutical item has the same meaning as in Part VII of the Act.
> drug is on F2 has the same meaning as in Part VII of the Act.
> electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
> electronic medication chart has the meaning given by subsection 41(6).
> electronic medication chart system means a software system that:
(a) is used for prescribing, and recording the administration of, pharmaceutical benefits to a person receiving treatment in or at:
(i) an approved residential care home in which the person is accessing funded aged care services through the service group residential care (within the meaning of the Aged Care Act 2024); or
(ii) an approved hospital; and
(b) is accessible in real time by approved suppliers for the purposes of:
(i) viewing electronic prescriptions written in electronic medication charts within the system; and
(ii) recording the supply information mentioned in paragraph 45(2)(d) in such electronic prescriptions; and
(c) meets any electronic medication chart system functionality requirements approved by the Secretary under section 12A.
> electronic order form means a form that is approved by the Secretary under subparagraph 33(1)(b)(ii) for the purposes of lodging an order under paragraph 33(1)(b).
> electronic prescription means a prescription that is prepared and submitted:
(a) in accordance with approved information technology requirements (if any), by means of an eligible electronic communication; and
(b) in accordance with:
(i) for prescriptions other than medication chart prescriptions—the form approved by the Secretary under subparagraph 40(2)(c)(ii); or
(ii) for medication chart prescriptions—either the form approved by the Secretary under paragraph 41(5)(a), or the information requirements approved by the Secretary under paragraph 41(5)(b), for the purpose of writing an electronic prescription.
> eligible electronic communication means:
(a) an electronic communication of a kind approved by the Secretary under section 11 for the purposes of the provision in which the expression is used; or
(b) if no such approval is in force for the purposes of the provision in which the expression is used—any electronic communication.
> entitlement card has the same meaning as in Part VII of the Act.
> exempt item has the same meaning as in Part VII of the Act.
> final day, of a data collection period, means the last day of the data collection period.
> funded aged care service has the meaning given by the Aged Care Act 2024.
> healthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010.
> healthcare provider organisation has the same meaning as in the Healthcare Identifiers Act 2010.
> incentive, for a brand of a pharmaceutical item, includes anything given as an incentive to take supply of the brand (including a delisted brand before it was delisted) whether the incentive is given:
(a) before the supply of the brand, but on condition of taking supply; or
(b) at, or after, the time of the supply of the brand; or
(c) over a period of time; or
(d) directly for the brand; or
(e) indirectly for the brand (for example, for a group of brands of pharmaceutical items or other products).
> information technology requirements has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
> initial month, for a brand of a pharmaceutical item that was not a listed brand immediately before the brand’s start day, means the first month of the brand’s first data collection period.
> last listed brand, of a pharmaceutical item, means the brand of the pharmaceutical item that was the last to become a delisted brand before the final day of the data collection period for the brand of the pharmaceutical item.
> listed brand has the same meaning as in Part VII of the Act.
> maximum quantity, of a pharmaceutical item or a pharmaceutical benefit, means the maximum quantity or number of units of the pharmaceutical item or pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion, as determined by the Minister under subsection 85A(2) of the Act.
> Medicare/DVA copy, for a paper‑based prescription, means the part of the prescription on which the words “Medicare /DVA copy” appear.
> medicare number has the same meaning as in Part VII of the Act.
> medication chart has the meaning given by subsection 41(4).
> medication chart prescription has the meaning given by subsection 41(1).
> optometrist has the same meaning as in Part VII of the Act.
> originator brand has the same meaning as in Division 3B of Part VII of the Act.
> out‑patient medication has the same meaning as in Part VII of the Act.
> paper‑based prescription means a prescription that is prepared in duplicate in accordance with paragraph 40(2)(a), (b) or (d).
> participating dental practitioner has the same meaning as in Part VII of the Act.
> PBS prescriber has the same meaning as in Part VII of the Act.
> pharmaceutical benefit has the same meaning as in Part VII of the Act.
> pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
> pharmaceutical item has the same meaning as in Part VII of the Act.
> pharmacist/patient copy, for a paper‑based prescription, means the part of the prescription on which the words “pharmacist/patient copy” appear.
> practitioner:
(a) in Division 1 of Part 4—has the meaning given by section 29; and
(b) in Division 2 of Part 4—has the meaning given by section 31.
> price adjustment means an adjustment under:
(a) a price agreement; or
(b) a price determination; or
(c) Division 3A of Part VII of the Act.
> price agreement has the same meaning as in Part VII of the Act.
> price determination has the same meaning as in Part VII of the Act.
> price disclosure requirements has the same meaning as in Division 3B of Part VII of the Act.
> price sampling day has the meaning given by section 68.
> pricing quantity has the same meaning as in Part VII of the Act.
> ready‑prepared pharmaceutical benefit means a pharmaceutical benefit in respect of which a determination made under subsection 85(6) of the Act is in force.
> record form has the same meaning as in Part VII of the Act.
> related brand, of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first‑mentioned pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item.
> relevant day has the same meaning as in Division 3B of Part VII of the Act.
> relevant entitlement period has the same meaning as in Part VII of the Act.
> relevant streamlined authority code, for a pharmaceutical benefit that is prescribed, means the streamlined authority code that is part of:
(a) the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or
(b) the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit.
> repatriation pharmaceutical benefit has the same meaning as in Part VII of the Act.
> repeat authorisation means a repeat authorisation prepared under subparagraph 52(3)(a)(i).
> repeat authorisation form means the form referred to in subparagraph 52(3)(a)(i).
> responsible person has the same meaning as in Part VII of the Act.
> Schedule equivalent has the same meaning as in Part VII of the Act.
> special patient contribution has the same meaning as in Part VII of the Act.
> start day, for a brand of a pharmaceutical item, means the day on which the brand was first required to comply with the price disclosure requirements under section 99ADD of the Act.
> value for safety net purposes has the same meaning as in Part VII of the Act.
> WADP brand has the meaning given by subsection 83(2).
> weighted average disclosed price has the same meaning as in Division 3B of Part VII of the Act.
(2) In this instrument, a reference to prescribing, or to the writing of a prescription, is a reference to the writing of a prescription for the supply of a pharmaceutical benefit under Part VII of the Act.
(3) In this instrument:
(a) a reference to the holder of a concession card or an entitlement card is a reference to a person who is, under section 84G of the Act, taken to be a holder of the card; and
(b) a reference to the original holder of a concession card is a reference to the person to whom a concession card has been issued under section 84DA of the Act; and
(c) a reference to the original holder of an entitlement card is a reference to the person to whom an entitlement card has been issued under section 84E of the Act; and
(d) a reference to a member of the family of a person is a reference to a person who is a member of that family within the meaning of section 84B of the Act.